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NCT Number: NCT07604688

Multicenter Registry Study of Patients With Intracranial Dural Arteriovenous Fistulas in China

This multicenter registry study aims to clarify the incidence trends of intracranial dural arteriovenous fistulas (IDAVF) and spinal dural arteriovenous fistulas (SDAVF) in China, evaluate current treatment patterns, and establish a nationwide multicenter retrospective and prospective database. The study is designed as a multicenter retrospective and prospective observational study involving more than 60 core hospitals across seven major geographic regions of China. The retrospective phase will include patients diagnosed between February 28, 2015 and February 28, 2025, while the prospective phase will enroll patients from March 1, 2025 to March 1, 2030. Eligible participants are patients diagnosed with IDAVF or SDAVF by digital subtraction angiography (DSA). The study will analyze disease incidence and temporal trends, collect baseline demographic and clinical characteristics, and evaluate treatment outcomes including obliteration rate, recurrence rate, and clinical prognosis. The crude incidence rate per 100,000 person-years during the study period will also be calculated based on Chinese census population data. The primary endpoint is the improvement rate in modified Rankin Scale (mRS) score at 6 months after treatment. Secondary endpoints include obliteration and recurrence rates on imaging follow-up at 6 months and improvement in mRS score at 12 months after treatment. Statistical analyses will be performed using SAS 9.4 software, including descriptive analyses as well as univariate and multivariate regression analyses to identify factors associated with clinical outcomes and prognosis.

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Key information

Conditions

Intracranial Dural Arteriovenous Fistula Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with intracranial dural arteriovenous fistula (IDAVF) or spinal dural arteriovenous fistula (SDAVF) by cerebral or spinal digital subtraction angiography (DSA)
  • Patients treated or evaluated at participating centers during the study period
  • Availability of complete clinical and imaging records, including baseline information, treatment records, and DSA images
  • For the prospective cohort, written informed consent signed by the patient or legal representative

Exclusion criteria

  • Patients with facial or scalp arteriovenous fistulas
  • Patients with non-dural vascular malformations or non-arteriovenous fistula vascular diseases, including cavernous malformations or venous malformations

Treatment and study plan

Endovascular

Procedure

This is a multicenter retrospective and prospective observational registry study of patients with intracranial dural arteriovenous fistulas (IDAVF) and spinal dural arteriovenous fistulas (SDAVF) in China. No experimental intervention will be assigned as part of the study. Diagnosis, treatment selection, and follow-up will be performed according to routine clinical practice at each participating center, including microsurgery, endovascular embolization, radiosurgery, conservative management, or combined treatment strategies when applicable. The study will collect demographic, clinical, angiographic, treatment, and follow-up outcome data to evaluate epidemiology, treatment patterns, obliteration rates, recurrence, and functional outcomes in a real-world multicenter cohort.

Primary outcomes

  1. Improvement in modified Rankin Scale (mRS) score at 6 months after treatment

    Time frame: 6 months after treatment

    The primary outcome measure is the proportion of patients demonstrating improvement in neurological functional status, as assessed by the modified Rankin Scale (mRS), at 6 months after treatment. Clinical outcomes will be evaluated through outpatient or telephone follow-up.

Secondary outcomes

  1. Angiographic obliteration and recurrence rates at 6 months after treatment

    Time frame: 6 months after treatment

    The secondary outcome measure includes angiographic obliteration and recurrence rates of intracranial or spinal dural arteriovenous fistulas at 6 months after treatment, as assessed by follow-up DSA, CTA, or MRA when available.

  2. Improvement in modified Rankin Scale (mRS) score at 12 months after treatment

    Time frame: 12 months after treatment

    The secondary outcome measure is the proportion of patients demonstrating improvement in neurological functional status, as assessed by the modified Rankin Scale (mRS), at 12 months after treatment. Clinical outcomes will be evaluated through outpatient or telephone follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Su, M.D

CONTACT

[email protected]

86-18210685023

Yongjie Ma, M.D

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

  • Affiliated Hospital of Shandong Second Medical University
  • Army Medical Center of PLA
  • Baotou Central Hospital
  • Beijing Haidian Hospital
  • Department of Neurosurgery and Junshan Brain Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Deyang People's Hospital
  • First Affiliated Hospital Xi'an Jiaotong University
  • First Affiliated Hospital of Fujian Medical University
  • First Affiliated Hospital of Harbin Medical University
  • First Affiliated Hospital of Jinan University
  • First Affiliated Hospital of Wenzhou Medical University
  • First Affiliated Hospital of Xinjiang Medical University
  • First Hospital of China Medical University
  • Fudan University
  • Fujian Provincial Hospital Affiliated to Fuzhou University
  • Gansu Provincial Hospital
  • Ganzhou People's Hospital, Jiangxi Province
  • General Hospital of Eastern Theater Command, Chinese People's Liberation Army
  • Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Guangdong Provincial People's Hospital
  • Guangdong Second Provincial General Hospital
  • Guangxi Hospital of the First Affiliated Hospital, Sun Yat-sen University
  • Henan Provincial People's Hospital
  • Huashan Hospital
  • Jiangsu Province Hospital (Department of Interventional Radiology)
  • Jining First People's Hospital
  • Lanzhou University Second Hospital
  • Liaoning Provincial People's Hospital
  • Linyi People's Hospital
  • Nanfang Hospital, Southern Medical University
  • Peking Union Medical College Hospital
  • Peking University First Hospital
  • Peking University International Hospital
  • Peking University Third Hospital
  • Qilu Hospital of Shandong University
  • Queen Elizabeth Hospital, Hong Kong Special Administrative Region
  • Second Affiliated Hospital of Nanchang University
  • Second Affiliated Hospital of Xi'an Jiaotong University
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Seventh Medical Center of PLA Army General Hospital
  • Shandong Provincial Hospital
  • Shanghai Donglei Brain Hospital
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • Sichuan Provincial People's Hospital
  • South China Hospital Affiliated to Shenzhen University
  • The Affiliated Hospital of Inner Mongolia Medical University
  • The Affiliated Hospital of Qingdao University
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
  • The First Affiliated Hospital of Air Force Medicial University
  • The First Affiliated Hospital of Anhui Medical University
  • The First Affiliated Hospital of Army Medical University (Southwest Hospital)
  • The First Affiliated Hospital of Dalian Medical University
  • The First Affiliated Hospital of Hainan Medical University
  • The First Affiliated Hospital of Nanchang University
  • The First Affiliated Hospital of Shanxi Medical University
  • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
  • The First Affiliated Hospital of Zhengzhou University
  • The First Affiliated Hospital with Nanjing Medical University
  • The First Hospital of Hebei Medical University
  • The First Hospital of Jilin University
  • The Second Affiliated Hospital of Air Force Military Medical University
  • The Second Affiliated Hospital of Chongqing Medical University
  • The Second Affiliated Hospital of Kunming Medical University
  • The Second Hospital of Hebei Medical University
  • The Third Medical Center of PLA General Hospital (Former General Hospital of the Chinese People's Armed Police Forces)
  • Third Affiliated Hospital, Sun Yat-Sen University
  • Tianjin Huanhu Hospital
  • Tianjin Medical University General Hospital
  • West China Hospital
  • Wuhan Central Hospital
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  • Yichang Central People's Hospital
  • Zhejiang University
  • Zhongshan Hospital Affiliated to Xiamen University
  • Zhujiang Hospital

Registry information

Official study title

Dural Arteriovenous Fistulas Registry, Evaluation, and Management Study in China (DREAM)

Acronym: DREAM

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 22, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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